Regulatory Officer - Clinical Trials

About the role

PSI, a Contract Research Organization with more than 25 years of experience, is looking for a Regulatory Officer to join its team of experts in regulatory and ethics submissions of clinical studies. The role focuses on facilitating the start of research projects for novel medicinal products.

Key responsibilities

• Prepare clinical trial documents for regulatory and ethics submissions
• Communicate with regulatory authorities and support communication with ethics committees, project teams and vendors on regulatory matters
• Review translations of essential documents required for clinical trial submission
• Track the regulatory project documentation flow
• Review documents to approve the release of intellectual property to sites
• Manage safety reporting to authorities
• Deliver regulatory training to project teams
• Assist with feasibility research and business development requests

Required profile

• College or university degree, or an equivalent combination of education, training and experience
• Prior experience with clinical trial submissions to ANVISA in Brazil
• Prior experience with regulatory activities for clinical trials
• Full working proficiency in English and Portuguese; Spanish is a plus

Required skills

• Proficiency in MS Office applications
• Detail-oriented, able to learn, plan and work in a dynamic team
• Communication, collaboration and problem-solving skills

What we offer

• Flexible working conditions
• Extensive training and a friendly, collegial team
• Competitive salary and benefits package
• Opportunities for personal and professional growth